The US Procures Ebola Treatment For National Preparedness

Don Hackett — Thu, 30 Jul 2020 19:34:34 +0000

Reviewer:

The Biomedical Advanced Research and Development Authority (BARDA) announced it entered an agreement to procure REGN-EB3 as part of the US government’s goal of building national preparedness for public health emergencies.

REGN-EB3 is New York-based Regeneron Pharmaceuticals, Inc. investigational triple antibody cocktail treatment for Ebola virus infection and is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a target action date of October 25, 2020.

Contingent on FDA approval, Regeneron said on July 29, 2020, expects to deliver to BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS), an established number of treatment doses over the course of 6-years.

In 2019, the randomized controlled PALM clinical trial conducted in the Democratic Republic of the Congo was stopped early when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm, ZMapp®.

REGN-EB3 demonstrated superior efficacy compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.

During the trial, there were 3 serious adverse events for REGN-EB3, compared to seven for ZMapp.

"The current COVID-19 pandemic provides an important lesson in preparation for potential biological threats to our nation's health security," said BARDA acting director Gary Disbrow, Ph.D., in a press statement.

"Whether the next one is another coronavirus, an Ebola virus, or a completely novel disease, we must do everything we can to be prepared."

REGN-EB3 is being developed with collaboration and funding provided by BARDA under ongoing USG Contract Nos. HHSO100201700016C and HHSO100201500013C.

Regeneron is a biotechnology company that invents life-transforming medicines for people with serious diseases.

Updated Ebola vaccine development news and availability can be found at this link.

Precision Vaccinations publishes Ebola treatment news.

Sub Title:

Regeneron Pharmaceuticals triple antibody cocktail REGN-EB3 treats Ebola virus infections

References:

BARDA PROCURES REGENERON'S REGN-EB3 INVESTIGATIONAL EBOLA TREATMENT FOR NATIONAL PREPAREDNESS

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Don Hackett — Fri, 17 Apr 2020 19:01:26 +0000

Reviewer:

Robert Carlson, MD

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a new Biologics License Application (BLA) for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection.

Regeneron Pharmaceuticals, Inc. announced that the target action date for the FDA decision is October 25, 2020.

The REGN-EB3 BLA is supported by data from the randomized, controlled PALM clinical trial conducted in the Democratic Republic of Congo.

In August 2019, the trial was stopped early when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm, ZMapp.

REGN-EB3 demonstrated superior efficacy compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.

"Developed using Regeneron's proprietary VelociSuite® rapid response technologies, REGN-EB3 was shown to save lives in the PALM trial, which evaluated multiple therapies against the current standard of care," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron, in a press release.

"Regeneron is now applying this same approach to develop an antibody medicine that can potentially prevent and treat COVID-19, with initial clinical trials expected to begin in June."

Regeneron's VelociSuite technologies enable the efficient creation and selection of potent fully-human antibodies against a specific biological target, which is particularly critical for addressing new and/or quickly-spreading pathogens that cause diseases such as Ebola and COVID-19.

These technologies facilitate the rapid cloning and generation of optimized fully-human antibodies from both VelocImmune® mice (which are genetically-engineered to have genetically-humanized immune systems) and convalescing human volunteers, and allow for the rapid escalation of fully-human antibodies into manufacturing-quality cell line production and large-scale bioreactor manufacturing.

Once strong therapeutic antibody candidates are identified, the company's in-house preclinical, clinical and commercial-scale manufacturing capabilities allow for fast scale-up and flexibility to adapt to the current need.

Previously, REGN-EB3 received Orphan Drug and Breakthrough Therapy designation from the FDA.

It is being developed under an ongoing collaboration and with funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Ebola therapeutic development news published by Precision Vaccinations.

Sub Title:

REGN-EB3 was developed on the same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy

Reference:

FDA ACCEPTS FOR PRIORITY REVIEW BIOLOGICS LICENSE APPLICATION FOR REGN-EB3 TO TREAT EBOLA

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